Klimakteriet i termoregulering
Påverkan av östrogen på de termoregulatoriska svaren på värmestress hos kvinnor före och postmenopaus
The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men.
Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Premenopausal and postmenopausal women will be recruited and different interventions will be given to each group. To mimic a postmenopausal hormone profile, premenopausal women will be given a GnRH antagonist, which acutely reduces estrogen concentrations. This induces a temporary post-menopausal state without compounding aging effects. Postmenopausal women will be given a transdermal estradiol patch to acutely raise estrogen concentrations. Supplementing estrogen in postmenopausal women allows for the effect of menopausal low estrogen concentration to be removed from the physiological effects of aging.
Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles.
Each subject will complete 6 (3 for each treatment) experimental trials. For each intervention, participants will complete one passive heating experiment first, followed by two active heating experiments.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: W. Larry Kenney, Ph.D.
- Telefonnummer: 814-863-1672
- E-post: w7k@psu.edu
Studera Kontakt Backup
- Namn: Olivia K. Leach, MS
- E-post: okl5046@psu.edu
Studieorter
-
-
Pennsylvania
-
University Park, Pennsylvania, Förenta staterna, 16802
- Rekrytering
- Noll Laboratory
-
Kontakt:
- W. Larry Kenney, Ph.D.
- Telefonnummer: 814-863-1672
- E-post: w7k@psu.edu
-
Kontakt:
- Olivia Leach, MS
- E-post: okl5046@psu.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Women ages 42-64
Exclusion Criteria:
- Chron's disease, diverticulitis, or similar gastrointestinal disease
- Abnormal resting exercise electrocardiogram (ECG)
- Tobacco use
- High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor
- Assessment
- Using hormone therapy
- Using hormonal contraceptives
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Premenopausal estrogen suppression
Participants take a cellulose placebo tablet for 4 days prior to baseline testing and continue until experimental visits are complete. Following completion of placebo testing, participants begin taking 400 mg/day Elagolix for 4 days prior to testing and continue until experimental visits are complete. |
2 x 200 mg tablet
Andra namn:
placebo tablet |
|
Experimentell: Postmenopausal estrogen supplementation
Participants wear a transdermal estradiol patch or placebo patch for 5 days prior to testing and continue until experimental visits are complete. After 48 hr washout, participants then wear the alternative treatment for 5 days prior to testing until experimental visits are complete. |
0.05 mg/day patch placebo patch |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Skin Blood Flow
Tidsram: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
Skin blood flow response to whole body heating is continuously monitored |
Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
|
Local Sweat Rate
Tidsram: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
A small sweat capsule is placed on the forearm for the duration of whole body heating. |
Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
|
Core Temperature
Tidsram: Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)
|
Changes in body temperature are measured through a telemetry pill swallowed before each experiment. |
Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body Mass
Tidsram: Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
Body mass is measured on a scale. |
Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
|
Skin Temperature
Tidsram: Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
Mean skin temperature is calculated from a weighted average of skin temperature from 4 different sites. |
Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: W. Larry Kenney, Ph.D., The Pennsylvania State University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Study 25435
Läkemedels- och apparatinformation, studiedokument
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